Brentuximab Vedotin for Systemic Sclerosis

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Diffuse Cutaneous Systemic Sclerosis, Scleroderma, dcSSc

In brief

There is significant unmet need for effective treatment options for Diffuse Cutaneous Systemic Sclerosis (dcSSc). The present study will be a dose-escalation safety trial of brentuximab vedotin, a drug-antibody conjugate approved for the treatment of lymphoma and targeted to the protein CD30 molecule expressed on activated immune cells There is evidence for CD30 involvement in SSc. This study represents the first step in determining safety and tolerability of brentuximab vedotin in SSc.

Key facts

Study ID

NCT03222492

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

17

Starts

2017-09-20

Expected to finish

2023-04-10

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Classification of Systemic Sclerosis (SSc), as defined using the 2013 American College of Rheumatology/European Union League Against Rheumatism classification of SSc;
• Diagnosis of Diffuse Cutaneous Systemic Sclerosis (dcSSc), as defined by LeRoy and Medsger, Criteria for the classification of early systemic sclerosis. J Rheumatol, 2001. 28(7): p. 1573-6;
• Disease duration ≤ 60 months (defined as time from the first non-Raynaud phenomenon manifestation);
• Modified Rodnan Skin Score (mRSS) units ≥ 15 and ≤ 45, and both of the following:
• At least mild skin thickening (≥ 1+ mRSS) of the forearm, and
• At least moderate skin thickening (≥ 2+ mRSS) at the planned forearm skin biopsy site.
• Documentation of at least 12 weeks of ongoing immunosuppressive therapy for SSc at the time of enrollment, and at least 4 weeks at a stable dose, of one of the following:
• Methotrexate ≤ 25 mg/week, or
• Mycophenolate mofetil ≤3 grams/day or mycophenolate sodium ≤2.16 grams/day, or
• Azathioprine ≤3mg/kg/day.
• Ability to provide informed consent.

You may not qualify if…

• Rheumatic disease other than Diffuse Cutaneous Systemic Sclerosis (dcSSc); it is acceptable to include patients with osteoarthritis, fibromyalgia, sicca symptoms, and scleroderma-associated myopathy;
• Limited cutaneous Systemic Sclerosis (SSc) or sine scleroderma;
• Pulmonary disease with Forced Vital Capacity (FVC) ≤60% of predicted, or Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) (corrected for hemoglobin) ≤60% of predicted;
• Pulmonary hypertension (PH) or moderate to severe left ventricular dysfunction, defined as one of the following:
• Transthoracic echocardiography demonstrating at least one of the following (unless subsequent right heart catheterization does not demonstrate PH; or unless prior right heart catheterization within one year did not demonstrate PH and echocardiography results are not significantly changed):
• Tricuspid regurgitation jet >2.8 m/sec or estimated right ventricular systolic pressure > 42 mm Hg. or
• At least one of the following:
• Abnormality of right atrial size, shape, or wall thickness consistent with PH, or
• Abnormality of right ventricular size, shape, or wall thickness consistent with PH, or
• Abnormal septal wall shape consistent with PH.
• Left Ventricular Ejection Fraction (LVEF) <50%.
• Right heart catheterization showing mean pulmonary artery pressure ≥25 mm Hg at rest;
• Current use of approved medications for PH. It is acceptable to use phosphodiesterase type 5 (PDE-5) inhibitors for Raynaud's, digital ulcers, and intermittently for erectile dysfunction.
• Active scleroderma renal crisis within the 4 months prior to enrollment;
• History of moderate-to-severe lower gastrointestinal dysmotility such as current use of parenteral nutrition and/or recent history of intestinal pseudo-obstruction within 3 months prior to enrollment;
• The following medications:
• Oral corticosteroids >10 mg/day of prednisone or equivalent within 2 weeks prior to enrollment;
• Treatment with Intravenous Immunoglobulin (IVIG) within 12 weeks prior to enrollment;
• Treatment with cyclophosphamide within 6 months prior to enrollment;
• Use of investigational biologic or non-biologic medication within the past 90 days, or 5 half-lives prior to enrollment, whichever is greater;
• Use of anti-TNF medication or other biologic medications within the past 90 days, or 5 half-lives prior to enrollment, whichever is greater;
• Prior treatment with anti-CD20 if either of the following are true:
• B cells ≤ lower limit of normal (LLN), or
• Treatment with anti-CD20 has been within 12 months prior to enrollment.
• Any prior treatment with cell-depleting therapies other than anti-CD20, including investigational agents, including but not limited to, CAMPATH(R), anti- CD4, anti-CD5, anti-CD3, anti-CD19; or

Where it is running

• UCLA Medical Center: Division of Rheumatology — Los Angeles, California, United States
• Georgetown University Medical Center: Division of Rheumatology — Washington D.C., District of Columbia, United States
• University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology — Ann Arbor, Michigan, United States
• Hospital for Special Surgery, New York: Division of Rheumatology — New York, New York, United States
• Duke University Medical Center: Division of Rheumatology and Immunology — Durham, North Carolina, United States
• University of Pittsburgh Medical Center: Division of Rheumatology and Clinical — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina: Division of Rheumatology & Immunology — Charleston, South Carolina, United States
• University of Texas Houston Medical School: Division of Rheumatology and Clinical Immunogenetics — Houston, Texas, United States

Full record on ClinicalTrials.gov

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